Guidance on Personal Use of Imported Prescription Drugs
Although importing unapproved prescription drugs is illegal, the FDA's guidance on importing prescription drugs for personal use recognizes that there may be circumstances in which the FDA can exercise discretion to not take action against the illegal importation.
The personal use guidance was first adopted in 1954, and it was modified in 1988 in response to concerns that certain AIDS treatments were not available in the United States. The guidance allows individuals with serious conditions, such as a rare form of cancer, to get treatments that are legally available in foreign countries but are not approved in the United States.
The current policy is not a law or a regulation, but serves as guidance for FDA personnel. The importation of certain unapproved prescription medication for personal use may be allowed in some circumstances if all of these factors apply:
- If the intended use is for a serious condition for which effective treatment may not be available domestically.
- If the product is not considered to represent an unreasonable risk.
- If the individual seeking to import the drug affirms in writing that it is for the patient's own use and provides the name and address of the U.S.-licensed doctor responsible for his or her treatment with the drug or provides evidence that the drug is for continuation of a treatment begun in a foreign country.
- If the product is for personal use and is a three-month supply or less and not for resale. Larger amounts would lend themselves to commercialization.
- If there is no known commercialization or promotion to U.S. residents by those involved in distribution of the product.
"While we can appreciate the cost issue, saving money on prescription drugs isn't one of the circumstances," says the FDA's McCallion. "The guidance doesn't condone the use of buying foreign-made versions of drugs available in the United States, even if they are sold under the same name," he says. "They are still unapproved products."
That means if you buy your high blood pressure or other medication from a foreign country because it's cheaper--even though a drug with the same name is approved for sale in the United States--generally the drug will be considered unapproved and the FDA's personal use guidance will not apply. The Drug Enforcement Administration has additional requirements for controlled drugs.
By Michelle Meadows www.fda.gov